Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 062592
Company: LILLY
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
KEFUROX CEFUROXIME SODIUM EQ 750MG BASE/VIAL INJECTABLE;INTRAVENOUS Discontinued None No No
KEFUROX CEFUROXIME SODIUM EQ 1.5GM BASE/VIAL INJECTABLE;INJECTION Discontinued None No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
01/10/1986 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/12/2002 SUPPL-26 Labeling

Label is not available on this site.

09/30/2002 SUPPL-25 Manufacturing (CMC)-Packaging

Label is not available on this site.

11/12/2002 SUPPL-24 Labeling

Label is not available on this site.

09/04/2002 SUPPL-23 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

06/24/2002 SUPPL-22 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

09/05/2001 SUPPL-21 Manufacturing (CMC)-Control

Label is not available on this site.

01/22/2001 SUPPL-20 Labeling

Label is not available on this site.

01/22/2001 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

01/22/2001 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

01/22/2001 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

08/15/1996 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

01/23/1997 SUPPL-14 Labeling

Label is not available on this site.

01/13/1997 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

01/23/1997 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

10/30/1992 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

06/12/1992 SUPPL-9 Labeling

Label is not available on this site.

06/12/1992 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

07/21/1986 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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